Justus v. Ethicon, Inc. et al

Filing 169

MEMORANDUM OPINION AND ORDER (Defendants' Motion for Summary Judgment) The 115 MOTION for Summary Judgment is GRANTED in part and DENIED in part, as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 12/21/2016. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION

JOYCE JUSTUS,
Plaintiff,
v.

Civil Action No. 2:12-cv-00956

ETHICON, INC., ET AL.,
Defendant.
MEMORANDUM OPINION AND ORDER

(Defendants’ Motion for Summary Judgment)
Pending before the court is a Motion for Summary Judgment [ECF No. 115]
filed by defendants Ethicon, Inc. and Johnson & Johnson (collectively “Ethicon”)
against plaintiff Joyce Justus. As set forth below, the defendants’ Motion is
GRANTED in part and DENIED in part.
I. Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel
on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat
pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven
MDLs, there are more than 58,000 cases currently pending, approximately 28,000 of
which are in the Ethicon MDL. In an effort to efficiently and effectively manage this
massive MDL, the court decided to conduct pretrial discovery and motions practice
on an individualized basis so that once a case is trial-ready (that is, after the court

has ruled on all summary judgment motions, among other things), it can then be
promptly transferred or remanded to the appropriate district for trial. To this end,
the court ordered the plaintiffs and defendant to submit a joint list of 200 of the oldest
cases in the Ethicon MDL that name only Ethicon, Inc., Ethicon, LLC, and/or Johnson
& Johnson. These cases became part of a “wave” of cases to be prepared for trial and,
if necessary, remanded. See Pretrial Order No. 193, In re Ethicon, Inc. Pelvic Repair

Sys. Prods. Liab. Litig., No. 2:12-md-002327, Aug. 19, 2015, available at
http://www.wvsd.uscourts.gov/MDL/ethicon/orders.html. Plaintiff ’s case was selected
as a Wave 1 case.
Ms. Justus was surgically implanted with Prolift on April 29, 2008 at Mission
Hospital in Asheville, North Carolina by Doctor Nancy S. Howden. Am. Short Form
Compl. ¶¶ 9–12 [ECF. No. 21]. She is a resident of North Carolina. Id. ¶ 4. Ethicon
moves for summary judgment on all of Ms. Justus’ substantive claims. Defs.’ Mem.
Supp. Mot. Summ. J. 1 [ECF No. 116].
II. Legal Standards
A. Summary Judgment
To obtain summary judgment, the moving party must show that there is no
genuine dispute as to any material fact and that the moving party is entitled to
judgment as a matter of law. Fed. R. Civ. P. 56(a). In considering a motion for
summary judgment, the court will not “weigh the evidence and determine the truth
of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). Instead, the
court will draw any permissible inference from the underlying facts in the light most

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favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587–88 (1986).
Although the court will view all underlying facts and inferences in the light
most favorable to the nonmoving party, the nonmoving party nonetheless must offer
some “concrete evidence from which a reasonable juror could return a verdict in his
[or her] favor.” Anderson, 477 U.S. at 256. Summary judgment is appropriate when
the nonmoving party has the burden of proof on an essential element of his or her
case and does not make, after adequate time for discovery, a showing sufficient to
establish that element. Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). The
nonmoving party must satisfy this burden of proof by offering more than a mere
“scintilla of evidence” in support of his or her position. Anderson, 477 U.S. at 252.
Likewise, conclusory allegations or unsupported speculation, without more, are
insufficient to preclude the granting of a summary judgment motion. See Dash v.

Mayweather, 731 F.3d 303, 311 (4th Cir. 2013); Stone v. Liberty Mut. Ins. Co., 105
F.3d 188, 191 (4th Cir. 1997).
B. Choice of Law
Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in
MDL cases such as this. The choice of law for these pretrial motions depends on
whether they involve federal or state law. “When analyzing questions of federal law,
the transferee court should apply the law of the circuit in which it is located. When
considering questions of state law, however, the transferee court must apply the state
law that would have applied to the individual cases had they not been transferred for

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consolidation.” In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig.,
97 F.3d 1050, 1055 (8th Cir. 1996) (internal citations omitted). In cases based on
diversity jurisdiction, the choice-of-law rules to be used are those of the states where
the actions were originally filed. See In re Air Disaster at Ramstein Air Base, Ger.,
81 F.3d 570, 576 (5th Cir. 1996) (“Where a transferee court presides over several
diversity actions consolidated under the multidistrict rules, the choice of law rules of
each jurisdiction in which the transferred actions were originally filed must be
applied.”); In re Air Crash Disaster Near Chi., Ill., 644 F.2d 594, 610 (7th Cir. 1981);

In re Digitek Prods. Liab. Litig., No. 2:08-md-01968, 2010 WL 2102330, at *7 (S.D.
W. Va. May 25, 2010).
If a plaintiff files her claim directly into the MDL in the Southern District of
West Virginia, however, I consult the choice-of-law rules of the state in which the
implantation surgery took place. See Sanchez v. Boston Scientific Corp., 2:12-cv05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17, 2014) (“For cases that originate
elsewhere and are directly filed into the MDL, I will follow the better-reasoned
authority that applies the choice-of-law rules of the originating jurisdiction, which in
our case is the state in which the plaintiff was implanted with the product.”). Ms.
Justus filed this case in the Western District of North Carolina and it was transferred
to the Southern District of West Virginia by order of the United States Judicial Panel
on Multidistrict Litigation. Conditional Transfer Order [ECF No. 3]. Thus, the choiceof-law principles of North Carolina guide this court’s choice-of-law analysis.

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The parties agree, as does this court, that these principles compel application
of North Carolina law. For tort claims, North Carolina generally applies the lex loci

delicti approach, which provides that “the state where the injury occurred is
considered the situs of the claim.” Harco Nat’l Ins. Co. v. Grant Thornton LLP, 698
S.E.2d 719, 722–23 (N.C. Ct. App. 2010). Here, the alleged injury occurred in North
Carolina, where Ms. Justus was implanted with the allegedly defective device. Thus,
I apply North Carolina’s substantive law to the tort claims in this case. For warranty
claims, North Carolina applies the “most significant relationship” approach, which
“requires the forum to determine which state has the most significant relationship to
the case.” Boudreau v. Baughman, 368 S.E.2d 849, 853–54 (N.C. 1988). North
Carolina courts have found that “the place of sale, distribution, delivery, and use of
the product, as well as the place of injury . . . to be the state with the most significant
relationship to the warranty claims.” Id. at 855–56. Thus, I also apply North
Carolina’s substantive law to the warranty claims in this case.
III.

Analysis
Ethicon moves for summary judgment on all of the plaintiff’s substantive

claims. Ms. Justus does not contest this motion with regard to strict products
liability,1 negligent manufacturing, negligent misrepresentation, negligent infliction
of emotional distress, breach of implied warranty for a particular purpose, unjust

The plaintiff’s Amended Short Form Complaint does not allege any strict liability claims. Am. Short
Form Compl. ¶ 13. However, Ethicon moves for summary judgment to the extent that the plaintiff’s
claims for failure to warn, manufacturing defect, and design defect might be deemed to assert strict
liability claims. Defs.’ Mot. Summ. J. ¶ 1. The plaintiff agrees that she will not pursue claims based
on strict liability. Pl.’s Resp. ¶ 1 [ECF No. 129].
1

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enrichment, common law fraud, fraudulent concealment, and constructive fraud. Pl.’s
Mem Supp. Resp. 4 n.2 [ECF No. 130]. Ethicon’s Motion for Summary Judgment is
GRANTED as to those claims.
Ms. Justus opposes Ethicon’s motion with regard to negligence, negligent
failure to warn, negligent design, breach of express warranty, breach of implied
warranty of merchantability, violation of consumer protection laws, and gross
negligence.2 Below, I apply the summary judgment standard to each remaining claim.
A. Negligent Failure to Warn
Under North Carolina law, “[n]o manufacturer . . . shall be held liable in any
product liability action for a claim based upon inadequate warning or instruction
unless the claimant” can satisfy three requirements. N.C. Gen. Stat. § 99B-5(a). First,
the claimant must establish “that the manufacturer . . . acted unreasonably in failing
to provide such warning or instruction.” Id. Second, the claimant must establish “that
the failure to provide adequate warning or instruction was a proximate cause of the
harm for which damages are sought.” Id. Finally, the claimant must establish either
of the following:
(1) At the time the product left the control of the manufacturer . . . , the
product, without an adequate warning or instruction, created an
unreasonably dangerous condition that the manufacturer . . . knew, or
in the exercise of ordinary care should have known, posed a substantial
risk of harm to a reasonably foreseeable claimant[; or] (2) After the
product left the control of the manufacturer . . . , the manufacturer or
seller became aware of or in the exercise of ordinary care should have
known that the product posed a substantial risk of harm to a reasonably
Ethicon does not address Count XVII (punitive damages) or Count XVIII (discovery and rule tolling).
I do not make any rulings as to those claims. Ethicon challenges several specific claims sounding in
negligence, but plaintiff points out that Ethicon does not separately challenge Count I (negligence). I
do not make any rulings as to any negligence claims beyond those discussed below.
2

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foreseeable user or consumer and failed to take reasonable steps to give
adequate warning or instruction or to take other reasonable action
under the circumstances.

Id.
Ethicon argues that, under subsection (c) of the same statute, the learned
intermediary doctrine shields it from liability. Defs.’ Mem. Supp. Mot. Summ. J. 9
(citing N.C. Gen. Stat. § 99B-5(c)). Subsection (c) provides:
“[N]o manufacturer or seller of a prescription drug shall be liable in a
products liability action for failing to provide a warning or instruction
directly to a consumer if an adequate warning or instruction has been
provided to the physician or other legally authorized person who
prescribes or dispenses that prescription drug for the claimant . . . .”
N.C. Gen. Stat. § 99B-5(c).
While I am not persuaded that the plain language of subsection (c) provides
the basis for application of the learned intermediary doctrine to the instant case,
“[t]here are indications that North Carolina courts would adhere to the learned
intermediary doctrine” in matters of product liability. Baraukas v. Danek Med., Inc.,
No. 6:97CV00613, 2000 WL 223508, at *4 (M.D.N.C. Jan. 13, 2000) (citing Foyle ex

rel. McMillan v. Lederle Labs., 674 F. Supp. 530, 535–36 (E.D.N.C. 1987)). In fact, in
Baraukas, the United States District Court for the Middle District of North Carolina
determined that the learned intermediary doctrine applied where the manufacturer
warned the plaintiff’s physician about bone screws. Id. Accordingly, consistent with
the courts that have addressed this issue before me, I assess Ms. Justus’ negligent
failure to warn claim under the learned intermediary doctrine.

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Here, I FIND that genuine disputes of material fact exist with regard to: (1)
whether Ethicon’s warning was adequate; and (2) whether the alleged inadequate
warning proximately caused the alleged harm to Ms. Justus. Therefore, Ethicon’s
Motion for Summary Judgment on the plaintiff’s negligent failure to warn claim is
DENIED.
B. Negligent Design
Under North Carolina law, a plaintiff alleging inadequate design first must
prove “that at the time of its manufacture the manufacturer acted unreasonably in
designing or formulating the product, [and] that this conduct was a proximate cause
of the harm for which damages are sought . . . .” N.C. Gen. Stat. § 99B-6(a). To
determine whether Ethicon acted unreasonably in designing the Prolift, North
Carolina requires that the following factors be considered:
(1) The nature and magnitude of the risks of harm associated with the
design or formulation in light of the intended and reasonably foreseeable
uses, modifications, or alterations of the product[;] (2) The likely
awareness of product users, whether based on warnings, general
knowledge, or otherwise, of those risks of harm[;] (3) The extent to which
the design or formulation conformed to any applicable government
standard that was in effect when the product left the control of its
manufacturer[;] (4) The extent to which the labeling for a prescription
or nonprescription drug approved by the United States Food and Drug
Administration conformed to any applicable government or private
standard that was in effect when the product left the control of its
manufacturer[;] (5) The utility of the product, including the
performance, safety, and other advantages associated with that design
or formulation[;] (6) The technical, economic, and practical feasibility of
using an alternative design or formulation at the time of manufacture[;]
(7) The nature and magnitude of any foreseeable risks associated with
the alternative design or formulation.

Id. § 99B-6(b). Additionally, a plaintiff must prove one of the following:

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(1) At the time the product left the control of the manufacturer, the
manufacturer unreasonably failed to adopt a safer, practical, feasible,
and otherwise reasonable alternative design or formulation that could
then have been reasonably adopted and that would have prevented or
substantially reduced the risk of harm without substantially impairing
the usefulness, practicality, or desirability of the product[; or] (2) At the
time the product left the control of the manufacturer, the design or
formulation of the product was so unreasonable that a reasonable
person, aware of the relevant facts, would not use or consume a product
of this design.

Id. § 99B-6(a).
Here, I FIND that genuine disputes of material fact exist with regard to: (1)
whether Ethicon acted unreasonably in designing the Prolift; and (2) whether Ethicon
unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable
alternative design, or whether the design or formulation of the product was so
unreasonable that a reasonable person, aware of the relevant facts, would not use it.
Therefore, Ethicon’s Motion for Summary Judgment on the plaintiff’s negligent
design claim is DENIED.
C. Breach of Express Warranty
Under North Carolina law:
(1) Express warranties by the seller are created as follows:
(a) Any affirmation of fact or promise made by the seller to the
buyer which relates to the goods and becomes part of the basis of
the bargain creates an express warranty that the goods shall
conform to the affirmation or promise.
(b) Any description of the goods which is made part of the basis of
the bargain creates an express warranty that the goods shall
conform to the description.
(c) Any sample or model which is made part of the basis of the
bargain creates an express warranty that the whole of the goods
shall conform to the sample or model.

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(2) It is not necessary to the creation of an express warranty that the
seller use formal words such as “warrant” or “guarantee” or that he have
a specific intention to make a warranty, but an affirmation merely of the
value of the goods or a statement purporting to be merely the seller's
opinion or commendation of the goods does not create a warranty.
N.C. Gen. Stat. § 25-2-313. Accordingly, any actionable express warranty under
North Carolina law must turn on a statement that is the “basis of the bargain.” North
Carolina law provides that a plaintiff need not prove contractual privity for her
express warranty claim to survive. Alberti v. Manufactured Homes, Inc., 407 S.E.2d
819, 825 (N.C. 1991) (“[O]ur case law has recognized that a direct contractual
relationship in the sale of the product itself is not a prerequisite to recovery for breach
of express warranty against the manufacturer.”)
Even if Ms. Justus relied only on Dr. Howden’s medical judgment in deciding
to have the Prolift implanted, a reasonable juror could find that Ms. Justus relied on
the express warranties of Ethicon as they were provided to Dr. Howden, which formed
the basis for Dr. Howden’s medical judgment. Cf. Michael v. Wyeth, LLC, No. CIV.A.
2:04-0435, 2011 WL 2150112, at *9 (S.D. W. Va. May 25, 2011) (denying summary
judgment on breach of express warranty because even though “plaintiff testified that
she did not rely on any statements made by defendants . . . she did rely upon her
doctors’ recommendations,” and as a result, “a presumption arises that
[manufacturer’s] affirmations were at least part of the ‘basis of the bargain’ that led
plaintiff to ingest [the] drugs”); Forst v. SmithKline Beecham Corp., 602 F. Supp. 2d
960, 972 (E.D. Wis. 2009) (denying summary judgment on express warranty claim
where plaintiff did not read drug manufacturer’s labeling but relied upon doctor’s
recommendations, and holding that “a reasonable jury could find that [defendant’s]
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representations to [doctor], which were then communicated to the [plaintiffs],
constitute an affirmation forming a ‘basis of the bargain’ for [plaintiff’s] use of
Paxil.”); Knipe v. SmithKline Beecham, 583 F. Supp. 2d 602, 625 (E.D. Pa. 2008)
(same).
Here, I FIND that genuine disputes of material fact exist with regard to: (1)
whether an express warranty was made; and (2) whether Dr. Howden, the implanting
physician, relied on the express warranty as the “basis of the bargain.” Therefore,
Ethicon’s Motion for Summary Judgment on the plaintiff’s breach of express
warranty claim is DENIED.
D. Breach of Implied Warranty of Merchantability
Under North Carolina law, “a warranty that the goods shall be merchantable
is implied in a contract for their sale if the seller is a merchant with respect to goods
of that kind.” N.C. Gen. Stat. § 25-2-314(1). For a good to be “merchantable,” it must
(a) pass without objection in the trade under the contract description;
and (b) . . . [be] of fair average quality within the description; and (c) [be]
fit for the ordinary purposes for which such goods are used; and (d) run,
within the variations permitted by the agreement, of even kind, quality
and quantity within each unit and among all units involved; and (e) [be]
adequately contained, packaged, and labeled as the agreement may
require; and (f) conform to the promises or affirmations of fact made on
the container or label if any.

Id. § 25-2-314(2). To establish a claim for breach of implied warranty of
merchantability, the plaintiff must demonstrate: “(1) the goods bought and sold were
subject to an implied warranty of merchantability, (2) the goods were defective at the
time of the sale, (3) the defective nature of the goods caused plaintiff’s injury, and (4)

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damages were suffered as a result.” Goodman v. Wenco Foods, Inc., 423 S.E.2d 444,
454 (N.C. 1992).
Because a reasonable juror could determine that Ethicon negligently designed
the Prolift, see supra Section III.B, a reasonable juror could likewise find that Ethicon
breached the implied warranty of merchantability. See N.C. Gen. Stat. § 25-2314(2)(b). Therefore, Ethicon’s Motion for Summary Judgment on the plaintiff’s
breach of implied warranty of merchantability claim is DENIED.
E. Violation of Consumer Protection Laws
Ms. Justus alleges a violation of North Carolina’s Unfair and Deceptive Trade
Practices Act (“UDTPA”), which governs unfair and deceptive claims. “In order to
establish a prima facie claim for unfair trade practices, a plaintiff must show: (1) [the]
defendant committed an unfair or deceptive act or practice, (2) the action in question
was in or affecting commerce, and (3) the act proximately caused injury to the
plaintiff.” Bumpers v. Cmty. Bank of N. Va., 747 S.E.2d 220, 226 (2013) (alteration in
original) (quoting Dalton v. Camp, 548 S.E.2d 704, 711 (2001)); see also N.C. Gen.
Stat. § 75-1.1. To show proximate cause in a claim stemming from misrepresentation,
a plaintiff must demonstrate reliance on the misrepresentation. Bumpers 747 S.E.2d
at 88. “Whether a trade practice is unfair or deceptive usually depends upon the facts
of each case and the impact the practice has in the marketplace.” Marshall v. Miller,
276 S.E.2d 397, 403 (1981) (citation omitted). “[T]here is no explicit statutory

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requirement of a showing of bad faith . . . [and] the intent or good faith belief of the
actor is irrelevant.” Id.
Ethicon moves for summary judgment on Ms. Justus’ UDTPA claim, arguing
that she cannot show proximate cause because she testified that she did not rely on
information in any brochures in deciding to use the Prolift. Ms. Justus puts forth
evidence that Ethicon actively withheld facts from her. I FIND that there are
material questions of fact as to (1) whether Ethicon committed an unfair or deceptive
act or practice, and (2) proximate causation.

Therefore, Ethicon’s Motion for

Summary Judgment on the plaintiff’s consumer protection claim is DENIED.
F. Gross Negligence
The North Carolina Supreme Court has said the following with regard to
ordinary negligence and gross negligence:
[T]he difference between the two is not in degree or magnitude of
inadvertence or carelessness, but rather is intentional wrongdoing or
deliberate misconduct affecting the safety of others. An act or conduct
rises to the level of gross negligence when the act is done purposely and
with knowledge that such act is a breach of duty to others, i.e., a
conscious disregard of the safety of others. An act or conduct moves
beyond the realm of negligence when the injury or damage itself is
intentional.

Yancey v. Lea, 550 S.E.2d 155, 158 (N.C. 2001) (emphasis omitted) (citing Brewer v.
Harris, 182 S.E.2d 345, 350 (N.C. 1971)).
Ethicon asserts, without elaboration, that Ms. Justus has not presented
sufficient evidence to establish the elements of gross negligence. Ms. Justus asserts
that there is a dispute of fact as to Ethicon’s conduct. Ethicon’s Reply acknowledges
that

Ms.

Justus

asserts

Ethicon

purposefully withheld
13

knowledge

about

complications associated with the Prolift, but Ethicon argues that Ms. Justus cannot
prove this.
Viewing the facts in the light most favorable to Ms. Justus, I FIND that there
is a material dispute of fact regarding the issue of gross negligence. Therefore,
Ethicon’s Motion for Summary Judgment on the plaintiff’s gross negligence claim is
DENIED.
IV. Conclusion
For the reasons discussed above, it is ORDERED that Ethicon’s Motion for
Summary Judgment [ECF No. 115] is GRANTED in part and DENIED in part. The
Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER: December 21, 2016

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